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This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSF-1 | Experimental | One drop bilaterally twice daily for at least 6 weeks |
|
| Vehicle | Placebo Comparator | One drop bilaterally twice daily for at least 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSF-1 | Drug | One drop bilaterally twice daily for at least 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events. | As this is a safety study, no efficacy outcome has been defined. | Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orasis Investigative Site | Newport Beach | California | 92663 | United States | ||
| Orasis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CSF-1 | One drop bilaterally twice daily for at least 6 weeks CSF-1: One drop bilaterally twice daily for at least 6 weeks |
| FG001 | Vehicle | One drop bilaterally twice daily for at least 6 weeks Vehicle: One drop bilaterally twice daily for at least 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CSF-1 | One drop bilaterally twice daily for at least 6 weeks CSF-1: One drop bilaterally twice daily for at least 6 weeks |
| BG001 | Vehicle | One drop bilaterally twice daily for at least 6 weeks Vehicle: One drop bilaterally twice daily for at least 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events. | As this is a safety study, no efficacy outcome has been defined. | Posted | Count of Participants | Participants | Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study. |
|
Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSF-1 | One drop bilaterally twice daily for at least 6 weeks CSF-1: One drop bilaterally twice daily for at least 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 23.1 | Systematic Assessment | All cases were mild in the CSF-1 and vehicle group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Regulatory Affairs | Orasis Pharmaceuticals, Ltd. | +972-9-8877745 | iris.meisner@orasis-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2022 | Oct 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016173 | Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Vehicle | Drug | One drop bilaterally twice daily for at least 6 weeks |
|
| Petaluma |
| California |
| 94954 |
| United States |
| Orasis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Orasis Investigative Site | Danbury | Connecticut | 06810 | United States |
| Orasis Investigative Site | Rock Island | Illinois | 61201 | United States |
| Orasis Investigative Site | Overland Park | Kansas | 66210 | United States |
| Orasis Investigative Site | Elizabeth City | North Carolina | 27909 | United States |
| Orasis Investigative Site | Fargo | North Dakota | 58103 | United States |
| Orasis Investigative Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Orasis Investigative Site | Kingston | Pennsylvania | 18704 | United States |
| Orasis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Orasis Investigative Site | Cedar Park | Texas | 78613 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Iris Color | Count of Participants | Participants | No | Participants |
|
| Manifest Refraction Spherical Equivalent (MRSE) | MRSE: is the measure which allows to identify if a person is myopic (nearsighted) < -0.5D; emmetropic (normal refractive condition) between -0.5D to <= +0.75D: or hyperopic (farsighted) >+0.75D. For this measure, only 1 eye per participant was considered: the worst of both eyes or, if equal, the right eye. | Number | eyes | eyes |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 118 |
| 0 |
| 118 |
| 21 |
| 118 |
| EG001 | Vehicle | One drop bilaterally twice daily for at least 6 weeks Vehicle: One drop bilaterally twice daily for at least 6 weeks | 0 | 60 | 0 | 60 | 15 | 60 |
|
| Conjuctival papillae | Eye disorders | MedDRA 23.1 | Systematic Assessment | All cases were mild in the CSF-1 and vehicle group. |
|
| Vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment | All cases were mild in the CSF-1 and vehicle group. |
|
| Instillation site pain | General disorders | MedDRA 23.1 | Systematic Assessment | All cases were mild, with 80% of them being described as stinging or burning, lasting between a few seconds and a minute. |
|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment | All cases were mild in the CSF-1 and vehicle group. |
|
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| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |